Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0VHXYA
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| ADC Name |
GQ1005
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| Synonyms |
GQ1005; HLX87
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| Organization |
GeneQuantum Healthcare (Originator);Shanghai Henlius Biotech
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Trastuzumab variant
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
DXd
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly (ring-opening derivative)
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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| Elimination |
A pharmacokinetic study revealed that this drug was mainly excreted in the feces. Another study determined that 67% of a dose was excreted in the feces. Unmetabolized DXd was found in the urine. Trastuzumab deruxtecan is rapidly cleared from systemic circulation. Estimated systemic clearance of trastuzumab deruxtecan is 0.42 L/day. DXd showed a systemic clearance of about 19.2 L/h.
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Breast cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
27.60%
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| Patients Enrolled |
Eligible participants are adults (≥18 years) with advanced/metastatic HER2-expressing solid tumors (IHC 1+/2+/3+ or HER2 mutations) who failed or are intolerant to standard therapy. Key inclusion criteria: ECOG 0-1, adequate organ function, measurable lesions per RECIST 1.1, and washout from prior therapies. Exclusion criteria include uncontrolled brain metastases, cardiovascular disease, significant pulmonary conditions, prior topoisomerase I inhibitor-ADCs, active infections (HIV/HBV/HCV), pregnancy, and unresolved toxicity >Grade 1 from prior treatments.
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| Administration Dosage |
GQ1005 will be administered intravenously every 21 days.
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| Related Clinical Trial | |||||
| NCT Number | NCT06154343 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, First-In-Human, Multicenter, Open-Label,Dose-Escalation and Extension Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors | ||||
| Primary Endpoint |
The study evaluates the safety and tolerability of GQ1005, including incidence and severity of adverse events (AEs) graded by NCI-CTCAE v5.0, dose-limiting toxicities (DLTs) during the first 21-day cycle, and determination of the maximal tolerance dose (MTD) or recommended phase II dose (RP2D) based on cumulative cohort data.
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| Other Endpoint |
The pharmacokinetics (PK) of GQ1005 will be assessed via maximum concentration (Cmax), time to peak concentration (Tmax), and area under the curve (AUC). Antitumor efficacy measures include overall response rate (ORR), duration of response (DOR), disease control rate (DCR), time-to-response (TTR), progression-free survival (PFS), and overall survival (OS), all evaluated per RECIST 1.1. Immunogenicity will be assessed by anti-drug antibody (ADA) formation.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
69%
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| Patients Enrolled |
Eligible participants are adults (≥18 years) with advanced/metastatic HER2-expressing solid tumors (IHC 1+/2+/3+ or HER2 mutations) who failed or are intolerant to standard therapy. Key inclusion criteria: ECOG 0-1, adequate organ function, measurable lesions per RECIST 1.1, and washout from prior therapies. Exclusion criteria include uncontrolled brain metastases, cardiovascular disease, significant pulmonary conditions, prior topoisomerase I inhibitor-ADCs, active infections (HIV/HBV/HCV), pregnancy, and unresolved toxicity >Grade 1 from prior treatments.
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| Administration Dosage |
GQ1005 will be administered intravenously every 21 days.
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| Related Clinical Trial | |||||
| NCT Number | NCT06154343 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, First-In-Human, Multicenter, Open-Label,Dose-Escalation and Extension Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors | ||||
| Primary Endpoint |
The study evaluates the safety and tolerability of GQ1005, including incidence and severity of adverse events (AEs) graded by NCI-CTCAE v5.0, dose-limiting toxicities (DLTs) during the first 21-day cycle, and determination of the maximal tolerance dose (MTD) or recommended phase II dose (RP2D) based on cumulative cohort data.
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| Other Endpoint |
The pharmacokinetics (PK) of GQ1005 will be assessed via maximum concentration (Cmax), time to peak concentration (Tmax), and area under the curve (AUC). Antitumor efficacy measures include overall response rate (ORR), duration of response (DOR), disease control rate (DCR), time-to-response (TTR), progression-free survival (PFS), and overall survival (OS), all evaluated per RECIST 1.1. Immunogenicity will be assessed by anti-drug antibody (ADA) formation.
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